Kornimate/medical-research-clean huggingface dataset:
an open-label extension trial to assess the safety of long-term treatment of rotigotine in early-stage parkinson's disease

Conditions: Early Stage Parkinson's Disease

Summary: the objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with early-stage idiopathic parkinson's disease

this is the open-label extension to the randomized, double-blind, placebo- and ropinirole-controlled sp513 trial that assessed the efficacy and safety and tolerability of the rotigotine patch in subjects with early-stage idiopathic parkinson's disease

Eligibility criteria:
inclusion criteria: * subjects who have completed six months of maintenance treatment in the sp513 double-blind trial exclusion criteria: * subjects who had an ongoing serious adverse event from sp513 double-blind trial that was assessed as related to study medication

Keywords: rotigotine neupro®
asp-ii: ancrod stroke program: ancrod (viprinex™) for the treatment of acute, ischemic stroke

Conditions: Stroke; Cerebral Ischemia; Brain Infarction

Summary: the primary purpose of this study is to determine whether a brief intravenous infusion of ancrod started within 6 hours of stroke onset improves functional outcome at 3 months.

with prior approval by the fda, an interim analysis for futility was performed when 500 subjects had been entered into the two parallel trials, nct00141001 and nct00300196. the analyses were reviewed by the data safety monitoring board, which recommended that both studies be terminated because of futility. this was done at a point where 650 subjects had been entered into both studies, combined, but analyses were conducted only on the initial 500 subjects. results of the abbreviated analysis will be found with study nct00141001 since that study contributed most of the subjects to the analysis.

Eligibility criteria:
inclusion criteria: * acute, ischemic stroke with first symptoms within 6 hours of beginning treatment * baseline nihss \> 5 exclusion criteria: * no intracranial, extravascular blood on ct * hypertension (systolic \> 185; diastolic \> 105) * baseline fibrinogen level \< 100 mg/dl * thrombocytopenia (\< 100,000 / mm3) * recent (\< 3 days) or anticipated (\< 5 days) use of a thrombolytic agent * recent (\< 14 days) or anticipated surgery

Keywords: stroke fibrinogen reperfusion thrombolysis
evaluation of effectiveness and safety of antegrade and retrograde approach of percutaneous coronary intervention for chronic total occlusions

Conditions: Chronic Total Occlusion of Coronary Artery

Summary: objective of this study is to 1) analyze the clinical, anatomical and periprocedural differences of patients who underwent a procedure related to coronary cto through the antergrade approach and retrograde approach; 2) analyze the success rate of the procedures and the incidence and patterns of complications; 3) compare and analyze long-term performances after the successful procedure; and 4) identify the independent factors that require a retrograde approach and the prognostic factor regarding long-term performances after use of each approach.


Eligibility criteria:
inclusion criteria: * patients aged\>=19 * patients who have a cto lesion in at least one or more epicardial coronary artery 2.5 mm in blood vessel diameter * patients who have symptoms of angina or objectively proven myocardial ischemia (asymptomatic myocardial ischemia, stable or unstable angina, non - -st-segment elevation myocardial infarction) * patients who voluntarily agreed to the protocol and the clinical follow-up plan (or let their representative do this), and signed the informed consent form approved by the irb of each study institute exclusion criteria: * patients who are pregnant or lactating or have childbearing potential patients in whom contrast medium and heparin are contraindicated or who are hypersensitive to them * patients in whom aspirin, clopidogrel, ticagrelor and prasugrel, cilostazol are contraindicated * patients scheduled to undergo a surgery, etc. that requires discontinuance of an antiplatelet drug within 12 months after participation in the study * acute st elevation myocardial infarction at the time of hospitalization * terminally ill patients with their life expectancy \< one year * patients who have serious diseases other than cardiac diseases that may affect limitation of residual life time or observation of the protocol (e.g. oxygen-independent chronic obstructive pulmonary disease, persisting hepatitis or serious hepatic insufficiency, severe renal disease, etc. be left up to the discretion of the investigator.)
study of pharmacologic manipulation of age (advanced glycation endproducts) levels in prostate cancer patients receiving androgen deprivation therapy

Conditions: Prostate Cancer

Summary: the purpose of this study is to look at the effect that the study drug opc has on age levels in patients with prostate cancer.

ages are a type of metabolite, or substance, found in the food. the age content in food is determined by the types of food you eat and also how you prepare your food. the researchers helping conduct this study have found a potential link between age levels and cancer. the purpose of this study is to see if oligomeric procyanidin complex (opc) has an effect on the age levels in your blood and to see if those age levels have an effect on your cancer.

Eligibility criteria:
inclusion criteria 1. confirmation of adenocarcinoma of the prostate that is documented by one of the following: pathology report or clinic note with documented history of prostate cancer. 2. subjects must be receiving adt with a gnrh agonist or antagonist, with or without an anti-androgen, with a current testosterone level documented to be \<50ng/dl at enrollment. subjects whose adt is interrupted may enroll or continue on study as long as the testosterone is documented to remain \<50ng/dl for the entire duration of study participation. subjects who have undergone orchiectomy are also eligible. 3. prior cytotoxic chemotherapy for metastatic prostate cancer; prior treatment with genomically-targeted agents, or provenge is allowed. 4. subjects must have adequate hematologic, renal, and hepatic function at baseline, as follows: * hematology parameters: anc \>1000/mcl, platelets \> 100,000/mcl, hgb \>8.0gm/dl * renal function: egfr of \> 45mls/min using cockgroft and gault formula (see appendix c). * liver function: total bilirubin ≤uln, ast and alt \<1.5xuln 5. able to swallow and retain oral medication 6. ecog performance status of 0 - 2 7. ability to sign written informed consent 8. testosterone level \<50ng/dl exclusion criteria 1. known allergy to grapes or grape seed 2. history of receiving more than 2 classes of adt. 3. current use of strong antioxidants (extracts from grape seed, milk thistle; pine bark, green tea, saw palmetto; resveratrol; flavonoids; catechins; ellagic acid), large quantities of red grapes, white button mushrooms, red wine. see section 4.7 for more details.
a study to select rational therapeutics based on the analysis of matched tumor and normal biopsies in subjects with advanced malignancies

Conditions: Metastatic Cancer

Summary: an open non-randomized study using biology driven selection of therapies. winther study will explore matched tumoral and normal tissue biopsies and will use a novel method for predicting efficacy of drugs. the aim is to provide a rational personalized therapeutic choice to all (100 %) patients enrolled in the study, harboring oncogenic events (mutations/ translocations/ amplifications, etc.) or not. the total number of patients treated in the study will be two hundred across all participating cancer centers (european countries -france; spain-, israel, usa and canada). all centers will realize the same study independently.


Eligibility criteria:
inclusion criteria: * informed consent * any histologic type of metastatic cancer, (except for lung and brain at us sites), in which histologic normal counterpart can be obtained. * progression by recist (response evaluation criteria in solid tumors) or other criteria on at least one prior regimen for advanced disease. * ability to undergo a biopsy or surgical procedure to obtain fresh tumor biopsy paired with its normal counterpart. * age from 18 years * life expectancy of at least 3 months * ecog performance status of 0 to 1 * measurable or evaluable disease according to recist 1.1 criteria * for u.s. sites, advanced cancer patients that have exhausted all effective therapy for their disease and have progressed after previous line of therapy (documented disease progression under last treatment received) and conventional methods of assigning new therapy would not be expected to increase survival by more than 3 months. exclusion criteria: * any patient that might require a lung or brain biopsy are excluded (at us sites) * alteration of organ function or hematopoietic function as defined by the following criteria: 1. serum aspartate transaminase (ast) and serum alanine transaminase (alt) \>2.5 x upper limit of normal (uln), except for patients with liver metastases, for which ast and alt \> 5.0 uln is the exclusion criteria. 2. bilirubin \> 2.0 uln 3. polynuclear neutrophil \< 1.5 x 109/l 4. platelets \< 100 x 10 9/l 5. hemoglobin \< 90 g/l 6. creatinine \> 1.5 uln 7. calcemia \> 1.5 uln 8. phosphatemia \> 1.5 uln * coagulation abnormality prohibiting a biopsy * symptomatic or progressive brain metastases detected by radio imaging, or meningeal * patient who received a personalized therapeutic treatment based on molecular anomaly during the treatment period prior to the winther directed treatment (defining the pfs1). hormonal therapy may be continued during winther suggested therapy. the exclusion of prior matched targeted therapy includes but is not limited to all targeted therapeutics that are ema approved and genomically matched to patients. if there are questions about whether or not a prior therapy is matched targeted treatment it will be agreed on by discussion between pis who are also clinical management committee members; the resolution should take place prior to starting winther directed treatment.
the effect of the medsentry system on medication adherence

Conditions: Heart Failure

Summary: the goal of this pilot study to evaluate the effect of the medsentry system, a multi-faceted medication adherence device and reminder system, on medication adherence and clinical outcomes in heart-failure (hf) patients. we will also evaluate the usability and satisfaction derived from using this system. we hypothesize that: 1. the use of the medsentry system will improve medication adherence in patients with a discharge diagnosis of hf. 2. the improvement in adherence correlates with fewer hospitalizations and emergency department (ed) visits. 3. the improvement in adherence correlates with better health-related quality of life.


Eligibility criteria:
inclusion criteria: * patients who have successfully completed the partners connected cardiac care program (cccp) * take at least 3 and no more than 10 different daily medications (including both prescription and non-prescription/over the counter medications) to treat heart failure (hf) and other comorbid disorders. * take medications no more than 4 specified times each day (i.e. morning, afternoon, early evening, bedtime). * the patient must be able to open a pill bottle independently. * the patient must be able to sort and manage their own medications. * hospitalization within the last 24 months. * have a telephone or cell phone. * live in the greater boston area. * the patients must speak, read and write english. * the patients must not be either vision or hearing impaired (i.e., unable to hear an alarm similar to a clock alarm or oven alarm). * patient must have an massachusetts general hospital (mgh) affiliated care provider. exclusion criteria: * dementia or other conditions precluding the participant from providing informed consent or from learning to use the medsentry pillbox. * home environment unsuitable for the medsentry pillbox and other installed equipment. * awaiting revascularization, cardiac resynchronization or heart transplant. * patients with a coexisting terminal illness like cancer or chronic renal failure (crf) requiring dialysis.

Keywords: heart failure congestive heart failure medication adherence medication compliance telemedicine telehealth
glycocalyx damage and beta-lactam antibiotics in surgical critically ill

Conditions: Critical Illness

Summary: gcx damage and its relationship to pharmacodynamics and pharmacokinetics of beta lactam antibiotics in critically ill hypothesis to be tested: gcx damage impairs pharmacodynamics and pharmacokinetics of beta-lactam antibiotics in critically ill patients. there is correlation between gcx damage and insufficient beta lactam levels in patients with commonly used dosing. the aim of the study: evaluation of relationship between gcx damage and pharmacodynamics and pharmacokinetics of beta-lactam antibiotics in critically ill. type of the study: observational. subjects: adult patients admitted to icu with beta-lactam antibiotic therapy (meropenem or piperacillin/tazobactam empirically or based on culture results). sample size calculation: 20 patients (expected correlation coefficient 0,6, alpha error = 0,05) will lead to power study = 0,89. intervention: none. data to be recorded and analyzed: demographics, type of patients (trauma, post surgical, medical, after cardiac arrest), severity score - apache ii, sofa, fluid balance, a presence of delirium, clinical outcome, sublingual microcirculation by sdf imaging will be recorded three times during antibiotic treatment at the time points for blood samples required for pharmacodynamics and pharmacokinetic analysis, microcirculatory data and perfused boundary region.


Eligibility criteria:
inclusion criteria: * adult patients admitted to icu with beta-lactam antibiotic therapy (meropenem or piperacillin/tazobactam empirically or based on culture results). exclusion criteria: * none.
effect of foot reflexology on preeclampsia

Conditions: Mild Pre-eclampsia

Summary: the aim of this study to investigate the effect of foot reflexology on mild preeclampsia during pregnancy

preeclampsia is defined as arterial hypertension identified for the first time after the 20th week associated with proteinuria. it affects 5% to 7% of all pregnant women. it is more common in primigravida women, women with previous early onset preeclampsia, in age greater than 40 years, previous history of preeclampsia, pre-pregnancy obesity, women who become pregnant with donor eggs, embryo donation and donor insemination. it is responsible for over 70 000 maternal deaths and 500 000 fetal deaths worldwide every year. there are many risk factors for it as: hypertension, diabetes mellitus, proteinuria, obesity, family history, null parity, multiple pregnancies, use of contraception, older women conception (\> 40) and thrombotic vascular disease,edema, renal failure, liver failure and hellp syndrome.complementary therapies such as massage and foot reflexology are used with patients of preeclampsia, it is to normalize the body's function, break down tension, alleviate stress, improve nerve function and blood supply throughout the body. this trial has two groups; one will receive anti-hypertensive drugs and the second will receive anti-hypertensive drugs+foot reflexology sessions for 8 weeks (30 min, 2 session/ week).

Eligibility criteria:
inclusion criteria: * their ages were ranged between 20-36 years old. * their body mass index was not exceeding 35 kg/m2. * all women were diagnosed as mild preeclampsia. * all women were primipara and multipara. exclusion criteria: * any fractures in foot. * foot ulcer \& infection. * open skin wound in foot. * history of stroke. * women less than 20 years and more than 36 years. * bmi more than 35 kg\\m2. * severe preeclampsia.

Keywords: foot reflexology - preeclampsia - proteinuria
a study to evaluate the effect of precision spectra™ programming features and lead options on patient outcomes

Conditions: Chronic Pain

Summary: the study is a prospective, on-label, multi-center, blinded, randomized controlled trial with a cross-over design to evaluate the effect of precision spectra™ scs system's programming features and lead options.

the study is a sub-study of relief - a global registry to evaluate long-term effectiveness of neurostimulation therapy for pain (nct01719055). the treatment will consist of permanent implant of a precision spectra™ scs ipg with either a 32 contact coveredge™ surgical lead or with more than 2 percutaneous leads after a successful trial. programming features and lead options of the precision spectra™ scs system will be evaluated up to 3 months post-ipg activation. following completion of the 3 month visit, subjects will continue to be followed for up to 36 months per the study requirements of the relief registry.

Eligibility criteria:
inclusion criteria: * meets relief registry criteria for inclusion * primary complaint of persistent or recurrent low back pain, with or without leg pain * signed a valid, irb/ec-approved informed consent form exclusion criteria: * meets any relief registry criteria for exclusion

Keywords: stimulation implantable pulse generator back pain chronic pain leg pain
effectiveness of a virtual reality game for pediatric pain and anxiety management during skin prick testing

Conditions: Acute Pain

Summary: this study investigated the effectiveness of virtual reality (vr) distraction, compared to book distraction and no distraction, in reducing pain and anxiety during a medical procedure in a pediatric population: the skin prick test. although this test has many advantages and is considered to be minimally invasive, it causes anxiety and painful discomfort in children. this study concerns children aged 4 to 7 years consulting for an allergic test. outcome measures include pain score, level of anxiety, vr measures, and satisfaction questionnaires.

the use of skin prick tests is considered a gold standard in the evaluation of allergic reactions. these tests involve depositing a drop or small amount of the allergen on the skin and pricking the skin to let the allergen penetrate the epidermis. although this test has many advantages and is considered to be minimally invasive, it causes anxiety and painful discomfort for children. managing pain and anxiety during skin prick testing is essential to prevent long-term adverse effects, especially in the case of future needle-stick interventions. to our knowledge, the studies investigating distraction methods effect on reducing anxiety and pain during skin prick tests in childrenremain limited. no study has yet investigated the value of vr as a distraction tool in this field. we postulate a greater decrease in child pain and child and parent anxiety in the rv and book conditions compared to the control group. we also postulate a larger effect for the rv group compared to the book group. in the vr group, we postulate the absence of an increase in post-immersion cybersickness symptoms. in last, we postulated a good satisfaction to distractions proposed, with a best score for rv distraction.

Eligibility criteria:
inclusion criteria: * speaking french regularly, * requiring a skin prick test exclusion criteria: * have an epilepsy disorder * have blindness

Keywords: children anxiety pain skin prick testing
treatment of nonunion fractures with mesenchymal stromal cells (mscs)

Conditions: Pseudoarthrosis of Bone; Pseudarthrosis; Non Union Fracture; Nonunion Bone Fracture

Summary: the goal of this study is to evaluate the bone regeneration capacity of bm-msc (bone marrow mesenchymal stromal cells), in patients with nonunion. bm-msc cultured are seeded on a collagen scaffold, included into autologous platelet-rich plasma (prp) clot, and implanted in the nonunion bone defect.

nonunion (pseudoarthrosis) is one of the most serious complications of bone fracture. even though different treatments have been used to repair nonunion bone defects, most of them have limitations, like morbidities, limited supply, frequent treatment failure, and high cost. based on the knowledge that msc have multipotential capacity of differentiation into bone, cartilage, fat, and endothelial cells, and also, play a key role in the process of bone formation and fracture repair. in this study, we evaluated the use the bone regeneration capacity of autologous or allogeneic bm-msc, as a potential therapeutic strategy to induce formation of new bone tissue and fracture healing. a bioengineering construct, constituted by mscs and a collagen scaffold, is incorporated into platelet rich plasma (prp) clot, wich is implanted at the nonunion site defect.

Eligibility criteria:
inclusion criteria: * post-traumatic nonunion diagnosis (pseudoarthrosis) with or without previous ortopaedic treatment * patients with or without previous orthopaedic treatment * presence of nonunion 9 month or more * ossification failure in the non-union area, with an approximate size of 0.5 to 4 cm length exclusion criteria: * evidence of infection at the nonunion site (osteomielitis) * evidence of cutaneous lesion at the site of pseudoartrosis * viral hepatitis b and c, hiv infection, syphilis and other viral and bacterial infections * autoimmune diseases * neoplastic diseases * pregnancy * major metabolic disorders * treatment with steroids * other conditions or circumstances that compromise the study participation according to medical criteria
comparison of efficacy between 100% platelet-rich plasma and 100% serum eye drops in dry eye disease

Conditions: Dry Eye Disease

Summary: dry eye disease (ded) is a common eye problem, affecting 5% to 50% of the world population. although the disease is not fatal, it substantially reduces quality of life and creates a high economic burden as high as over 50 billion from a societal perspective. several biological tear substitutes (e.g., autologous serum (as), autologous platelet rich plasma (aprp), and autologous platelet lysate (apl)) could effectively improve dry eyes, especially in patients with moderate to severe ded.. however, evidence on their comparative efficacy is controversial. the objective of the study is to compare the efficacy of 100% aprp with 100% as eye drops in patients with moderate to severe ded.

the study is a single-center, double-blinded randomized, parallel, non-inferiority trial. patients will be recruited from out-patient clinic, department of ophthalmology, ramathibodi hospital, bangkok and will be randomized to receive either 100% aprp or 100% as eye drops (1:1 ratio) for 4 weeks. the primary outcomes include ocular surface disease index (osdi) and ocular surface staining evaluated using the oxford scale. secondary outcomes are fluorescein break-up time (fbut), schirmer's i test (st i), meibomian gland parameters and adverse events.

Eligibility criteria:
inclusion criteria: * aged 18 to less than 75 years. * have osdi scores ≥ 23 or oxford staining grade ≥ 2. * do not have following conditions: uncontrolled systemic diseases, active infection, advanced cancer. pregnant and nursing women. • have not recently used the following medications/interventions/surgery: anticoagulants or anti-platelets. topical undiluted blood products within 3 months. punctal plug or contact lenses. ocular surgery within 6 months. * do not have active ocular infection/inflammation, abnormal eyelid function or severe meibomian gland dysfunction (mgd stage 4). * have no contraindication for blood donations: positive human immunodeficiency virus, hepatitis b or c, or syphilis. anemia (hb \< 11 g/dl) or platelet concentration \< 150,000/ml. * being able to stop current dry eye treatment for 48 hours before staring trial intervention * willing to comply with the 4-week study protocol and provide informed consent. exclusion criteria: • none